# FDA WARNING_LETTER - Thorn Ford Dental Laboratory LLC - February 25, 2015

Source: https://www.globalkeysolutions.net/records/warning_letter/thorn-ford-dental-laboratory-llc/a3e1ffa6-dd0a-4ed8-9f89-4f95d4f8f7e3

> FDA WARNING_LETTER for Thorn Ford Dental Laboratory LLC on February 25, 2015. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Thorn Ford Dental Laboratory LLC
- Inspection Date: 2015-02-25
- Product Type: Devices
- Office Name: Seattle District Office
- Summary: On February 5-25, 2015, an FDA inspection of Thorn Ford Dental Laboratory LLC in Bothell, Washington, revealed that their TAP® 3 TL, Elite TL, and Silent Partner anti-snoring/obstructive sleep apnea devices were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The firm's March 5, 2015, response to the FDA 483 was deemed inadequate.

Key violations included:
1.  **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: No procedures were available, and the submitted policies lacked appropriate statistical methodology, verification/validation processes, analysis of diverse quality data sources, and provisions for management review.
2.  **Failure to establish and maintain complaint handling procedures (21 CFR 820.198(a))**: No procedures were available, and submitted documents did not formally designate a complaint unit or clarify complaint applicability.
3.  **Failure to establish and maintain purchasing controls (21 CFR 820.50)**: No documentation for supplier evaluation/selection or agreements for supplier notification of changes. The firm had taken no action on this.
4.  **Failure to establish and maintain finished

## Related Officers

- [Miriam R. Burbach](https://www.globalkeysolutions.net/people/miriam-r-burbach/68959b72-6f58-4d4b-9329-5109ffe8a649)
- [Margarete R. Ford](https://www.globalkeysolutions.net/people/margarete-r-ford/33f28c20-8342-4e35-8292-1752fb0e0b15)

Company: https://www.globalkeysolutions.net/companies/thorn-ford-dental-laboratory-llc/2edb0f3b-da09-4297-9cdf-68ba14b2c9b4

Office: https://www.globalkeysolutions.net/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913